Food and Drug Administration, cancer and Recall
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First GLP-1 drug approved to protect against heart attacks, stroke
The FDA has approved Rybelsus, the first oral GLP-1 receptor agonist, to reduce cardiovascular risk in type 2 diabetes patients. The drug can be prescribed to reduce major adverse cardiovascular issues even in patients who have not yet experienced these events.
Health and Human Services Secretary Robert F. Kennedy Jr. and Food and Drug Administration (FDA) Commissioner Marty Makary will give remarks on the Trump administration’s push to lower drug
The U.S. Food and Drug Administration announced it will relax certain rules for approving low-cost versions of some high-priced medications to reduce costs.
The FDA’s effort to expedite reviews for drugs in line with the Trump administration’s priorities was greeted warmly by a pharmaceutical industry interested in moving approvals more quickly, but raised concerns about the scope of the plan in light of recent cuts at the agency.
Food and Drug Administration has warned four companies that it plans to take enforcement action over their sale of unapproved fluoride-based prescription drugs for children, the agency said on Friday.
Two new deaths and seven more illnesses have been reported in an expanding outbreak of listeria food poisoning tied to recalled pasta meals sold at grocery stores including Walmart and Trader Joe's in many states.
The FDA is planning to speed approvals of highly similar copies of expensive biologic drugs, the latest effort in President Donald Trump’s aggressive agenda to lower costs for medicines in the US.
The Trump administration is proposing changes to Food and Drug Administration guidelines that would make it less expensive for drugmakers to develop biosimilar medicines, the copycat versions of off-patent biologic drugs.
Federal regulators are trying to make it easier to develop cheaper alternatives to powerful drugs that many Americans depend on to treat autoimmune diseases or cancers.
Texas Attorney General Ken Paxton alleged Johnson & Johnson deceptively marketed the drug as safe for pregnant Texans.